atomoxetine for children with acquired attentional disorders following completion of chemotherapy for all

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this study is a double-blind, placebo-controlled, parallel group trial of atomoxetine (1.8 mg/kg) for the management of chemotherapy-related acquired attentional disorders in children who have survived acute lymphocytic leukemia. atomoxetine will produce a favorable impact on adhd symptoms in children with chemo-related acquired attentional disorders.

the primary objective of this study is to assess the safety, tolerability and efficacy of atomoxetine as determined by the change in the adhd-rs-iv total score compared to placebo in the symptomatic treatment of patients diagnosed with attention-deficit/hyperactivity disorder (by dsm-iv adhd-nos criteria) occurring as a neuropsychological late-effect of chemotherapy used to treat acute lymphocytic leukemia (all). the secondary objectives are: 1. to assess the effect of once daily (am) dosing of atomoxetine (1.8mg/kg) compared to placebo on adhd symptoms as measured by: * adhd-rs total score inclusive of subtypes for inattention, hyperactivity and combined subtypes. * clinical global impression-adhd 2. to evaluate the safety and tolerability of atomoxetine compared with placebo based on treatment-emergent adverse events (aes), laboratory tests, vital signs, physical examinations, and ecgs.

Eligibility criteria:
inclusion criteria: * ages 6-18 years * must have successfully completed treatment for all and are currently 1-year "disease free" as judged by the investigators. * must meet dsm-iv criteria for "adhd-nos.( attachment a) the attention deficit symptoms have been precipitated by chemotherapy-related neurological injury. therefore, the dsm-iv category is adhd-nos. * must have an investigator-completed adhd-rs total and/or subscale score of ≥1.5 standard deviations above age/gender norm. * laboratory results, including chemistries, hematology, and urinalysis do not demonstrate clinically significant abnormalities. * ecg demonstrates no clinically significant abnormalities * educational level and degree of understanding of the patient and their parents permit suitable communication between the investigators and study coordinators. * subjects and parents are judged to be reliable to keep appointments. * must be able to swallow tablets. * must have demonstrated compliance during their chemotherapy program. * must weigh \> 20 kg. exclusion criteria: * have relapsed or are having re-occurring symptoms/signs of all. * have had substantial exposure to radiation therapy (\>2000: cgy) since high dose radiation treatment is associated with neurocognitive deficits or be "treatment resistant" pharmacologically. * past exposure to atomoxetine. * adhd symptoms or treatment prior to the diagnosis of all * documented bipolar disorder, psychosis, affective disorder. * female subjects who are pregnant or breastfeeding. * suicide risk. * seizure disorders (except history of febrile seizures). * histories of multiple drug allergies. * histories of alcohol or substance abuse. * prior or current medical conditions that, in the opinion of the investigators, could be exacerbated by atomoxetine. * sympathomimetic overactivity such as catecholamine secreting tumor. * use of maoi medications. * have taken psychostimulants one week prior to randomization. * current or past history of hypertension.

Keywords: attention deficit hyperactivity disorder